A systematic review and meta-analysis of drug-coated balloon versus conventional balloon angioplasty for dialysis access stenosis

J Vasc Surg. 2019 Sep;70(3):970-979.e3. doi: 10.1016/j.jvs.2019.01.082.

Abstract

Background: Arteriovenous fistulas for patients undergoing hemodialysis (HD) are at high risk of stenosis. Despite conventional balloon angioplasty (CBA), restenosis rates are high. The use of a drug-coated balloon (DCB) may offer an alternative to reduce restenosis.

Methods: This study has been performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. An electronic search on MEDLINE, Embase, and the Cochrane Library was performed to identify articles evaluating DCB angioplasty for patients with HD access stenosis. Risk ratios (RRs) of primary patency were pooled, and relevant subgroup and sensitivity analyses were conducted.

Results: There were 17 studies (8 randomized controlled trials [RCTs], 9 cohort studies) included, comprising a total of 1113 stenotic dialysis accesses, of which 54.7% underwent DCB angioplasty and 45.3% underwent CBA. There was a significantly superior 6-month (RR, 0.57; 95% confidence interval [CI], 0.44-0.74; P < .00001; I2 = 62%) and 12-month (RR, 0.73; 95% CI, 0.63-0.84; P < .0001; I2 = 53%) primary patency in the DCB angioplasty group in comparison to the CBA group (71.0% vs 49.2% at 6 months; 44.2% vs 20.6% at 12 months). Subgroup analyses of study design (RCTs, cohort studies) showed similar trends. Sensitivity analyses by excluding one poor-quality RCT and those employing the crossover analysis design also showed similar results. Studies investigating central venous stenosis showed significantly better 6-month (RR, 0.57; 95% CI, 0.41-0.79; P = .0009; I2 = 67%) and 12-month (RR, 0.69; 95% CI, 0.56-0.85; P = .0004; I2 = 64%) primary patency in the DCB angioplasty group in comparison to the CBA group. The pooled rate of minor complications was low in both the DCB (1.1%) and CBA (0.9%) groups.

Conclusions: DCB angioplasty appears to be a better and safe alternative to CBA in treating patients with HD stenosis in terms of 6- and 12-month primary patency. However, a larger trial is warranted to establish these findings.

Keywords: Central venous stenosis; Conventional balloon angioplasty; Dialysis access stenosis; Drug-coated balloon.

Publication types

  • Meta-Analysis
  • Systematic Review

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Angioplasty, Balloon / adverse effects
  • Angioplasty, Balloon / instrumentation*
  • Arteriovenous Shunt, Surgical / adverse effects*
  • Cardiovascular Agents / administration & dosage*
  • Cardiovascular Agents / adverse effects
  • Coated Materials, Biocompatible*
  • Equipment Design
  • Female
  • Graft Occlusion, Vascular / etiology
  • Graft Occlusion, Vascular / physiopathology
  • Graft Occlusion, Vascular / therapy*
  • Humans
  • Male
  • Middle Aged
  • Renal Dialysis*
  • Risk Factors
  • Time Factors
  • Treatment Outcome
  • Vascular Access Devices*
  • Vascular Patency

Substances

  • Cardiovascular Agents
  • Coated Materials, Biocompatible